Frequently Asked Questions
1. Does my research project need Research Ethics Board approval?
Research Ethics Board (REB) approval is required when conducting research with living people, with information provided by living people or with human biological materials (from living or deceased individuals).
For the purposes of research involving humans, research is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. Human participants are defined as individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research questions (TCPS article 2.1).
Research involving humans includes conducting research, including data analysis, with information provided by human participants, regardless of whether or not that information was collected by you (for instance, it could be provided by a data custodian or shared by a research team member).
Research involving humans that involves multiple jurisdictions may require the oversight of multiple research ethics boards. Multi-jurisdictional research is described in TCPS chapter 8. See FAQ #2 for review of multi-jurisdictional research at Dalhousie.
For more detailed information, Dalhousie University researchers should contact Research Ethics at email@example.com or phone 902.494.3423. Researchers at other institutions should contact their respective Research Ethics advisors.
2. I have REB approval through another institution. Do I need to get Dalhousie REB approval too?
Maybe. Pursuant to the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans (Chapter 8), Dalhousie is accountable for research conducted under its auspices no matter where the research is taking place. At Dalhousie, the review process for multi-jurisdictional research will depend on the situation.
A. Research approved by the NSHA, IWK or HHN REBs - Dalhousie University has formal agreements with the Nova Scotia Health Authority, Horizon Health Network (NB) and the IWK Health Centre. If a research study has been approved by one of their research ethics boards, Dalhousie researchers do not additionally require REB approval at Dalhousie, regardless of their role on the project.
Process – No additional application is required. Dalhousie is notified of research projects involving Dalhousie researchers approved by these boards directly. If your project receives funding administered by Dalhousie University, you may need to submit your affiliated REB approval to post-award staff in the Office of Research Services to open your research account.
B. Research approved by another TCPS-compliant institution (Dalhousie researcher is not the PI or co-PI) – If the research has already received research ethics board approval from another TCPS-compliant institution and a Dalhousie researcher is NOT the Principal Investigator, the nominated Principal Investigator or a Co-Principal Investigator for the study, the research may be eligible for board of record review. See the Application for Board of Record Review Acknowledgement Form for the full list of eligibility criteria. Importantly, the full scope of the research involving humans with which Dalhousie will be affiliated must be described and approved by the board of record.
Process – Apply for Board of Record Review Acknowledgement. The Research Ethics Board will issue an acknowledgment letter recognizing the REB from the other TCPS-compliant institution as the board of record for the research project.
C. Research approved by a another TCPS-compliant institution where a Dalhousie researcher is the PI or co-PI – If a Dalhousie researcher is the PI, nPI or co-PI on the project, or is the researcher with primary administrative or financial responsibility for the project, or the researcher responsible for leadership of the project, it must undergo Dalhousie REB review and approval.
Process – Apply for Dalhousie REB approval. If the full scope of Dalhousie’s involvement is described in another REB submission, you may submit the bulk of your submission on the other institution’s forms (see instructions below).
Applying for Dalhousie REB approval on another institution’s forms
Submit the following:
- Section 1 of the Dalhousie research ethics application form
- The full application to the other institution (including appendices)
- The review material from the other institution’s REB
- The approval letter from the other institution’s REB
When making a submission using another institution’s REB forms, it is the researcher’s responsibility to ensure that all the components of the Dalhousie research ethics application are addressed in the other research ethics documentation. If any components are missing, the researcher should address these to the board through a cover letter. For example, researchers are advised to comment on whether or not any provincial privacy legislation is relevant to the research project, such as the Personal Information International Disclosure Protection Act or the Personal Health Information Act.
This process is appropriate only when the research involving humans with which Dalhousie will be affiliated is described in the approved submission. If the project that will be completed under the auspices or jurisdiction of Dalhousie differs from what is described, a Dalhousie REB submission (on Dalhousie forms) must be made.
D. Research approved by a non TCPS-compliant institution - If the research has already received research ethics board approval from another institution that is not compliant with the TCPS (e.g. a non-Canadian institution), the research will require Dalhousie REB review and approval regardless of the role of the Dalhousie researcher.
Process – Apply for Dalhousie REB approval.
3. How long does it take to hear back about a research ethics submission?
It normally takes about 4 weeks to receive a response from the Research Ethics Board (REB). In most cases, your first response to a new research ethics application will be a review letter in which the REB requests further information or makes recommendations for changes.
When you respond to this initial review letter, it can take another 4 weeks to provide another REB review of your submission. You should plan at least 8 weeks from submission to approval, and this estimate is highly variable depending on the nature of the project, the quality of the initial ethics submission and the timeliness of communication between the researcher and the REB.
After you receive REB approval, you may find that you would like to make changes to your project. If this is the case, you will need to submit an amendment request [DOC] to the board. Again, you should plan for about 4 weeks to have your amendment request assessed and the review to be communicated with you.
If your research extends 12 months or more beyond the initial REB approval date, you will need to submit an annual report [DOC - 69 KB] for continuing review. This should be submitted at least 21 days prior to the current approval’s expiry date (which will be found on your approval letter).
Please note that there are no research ethics reviews in August.
4. Is there anything the researcher can do to speed up the REB review process?
Some parts of the review process will be beyond your control. There are an increasing number of submissions and each must be reviewed by the research ethics staff, board chair and by volunteer board members who give it careful ethical review and prepare written feedback for you. This takes time.
The best way you can contribute to a speedier review process is to submit a carefully prepared application that highlights the ethical considerations relevant to your study. You should read the application and submission instructions carefully and provide the requested information.
It is also highly recommended that you complete the online Course on Research Ethics.
5. Does program evaluation and quality improvement/assurance require research ethics review?
Research requires REB review, but program evaluation, quality assurance and quality improvement activity is exempt from REB review (as per TCPS 2.5). The Panel on Research Ethics offers more interpretation of this question on its website (Scope – Questions 2 and 7).
It is often difficult to determine what activities qualify for an exemption from research ethics review. The Dalhousie Research Ethics boards have developed Guidelines for Differentiating Among Research, Program Evaluation and Quality Improvement [PDF - 45 kB]. The guidelines intended to guide researchers and evaluators (including students) as they determine whether their proposed activity constitutes research, program evaluation (PE), or quality improvement (QI), and therefore whether it requires research ethics review or is exempt.
Please note that intent to publish does not in itself determine whether the activity is research (therefore requiring REB review).
6. Do I need to use a written consent form that I ask participants to sign?
No. There is a whole chapter devoted to the consent process in the TCPS (Chapter 3). You must ensure that consent is documented (TCPS 3.12), but that documentation does not need to be a written consent form, although this format is common and appropriate in many instances.
Researchers should consider the most appropriate means of ensuring potential participants receive all the information necessary to make an informed decision about whether or not to participate in research (TCPS 3.2 details the required elements of informed consent) as well as the most appropriate way to document a participant’s consent, and describe this fully in the research ethics submission.
Sample consent forms are available in the Resources section.
7. I would like to use data from a colleague (or database). I will receive the data in a de-identified format (all identifiable information will be removed). Do I need to get REB approval?
Yes. REB review is not required for research that relies exclusively on secondary use of anonymous information (TCPS 2.4). Anonymous information is information that never had identifiers associated with it (TCPS p. 59). Although you may be receiving the information in an “anonymous” format, the fact that the data was once identifiable means that the research doesn’t qualify for an exemption from REB review according to the TCPS.
8. How long should I keep my data?
Dalhousie University does not have a policy on the duration of retention of research information. The Panel on Research Ethics offers more interpretation of this question on its website (Question 5). It is common to keep data for five years, but there is normally no requirement to do so.
From a research ethics perspective, the most important consideration is protecting the privacy and confidentiality of research participants who have entrusted you with their information. Sometimes, participants have no expectation of privacy, other times, there are very high expectations. However long you propose to keep research-related information (consent forms, participant codes, video/audio tapes, survey answers, interview transcripts, datasets, biological materials, etc.), you should carefully consider how long you actually need to keep identifiable information. Generally, more identifiable the information, the safer it is not to keep it in an identifiable form. However, there is also no requirement to destroy data after a set period of time. The TCPS states that “researchers shall provide details to the REB regarding their proposed measures for safeguarding information, for the full life cycle of information: its collection, use, dissemination, retention and/or disposal” (article 5.3). You may choose to retain research data longer term; if so, please describe the rationale, if and how the data will be anonymized or destroyed, and how appropriate security safeguards will be in place for the full life cycle of information (5.3 (e)).
9. I am a graduate student. Should I submit my research ethics application before or after my thesis proposal has been approved by my supervisory committee?
After. You must have your supervisory committee approval first. Your committee may offer recommendations that will require changes to your research project. This is the project you should present to the Research Ethics Board for ethical review.
10. I want to conduct an online survey as part of my research. What tool should I use?
The REB recommends the use of Opinio or REDCap for web-based survey research. Opinio is a Dal hosted and supported tool researchers can use to collect survey information online. The survey data from Opino are stored on Dalhousie servers and therefore helps researchers adhere to various pieces of privacy legislation, and the Dalhousie Policy for the Protection of Personal Information from Access Outside Canada.
REDcap is a secure web application for building and managing online surveys and databases. Like Opinio, the data are stored on Dalhousie servers and similarly upholds the same privacy legislation and Dalhousie Policies mentioned above. Some researchers will find REDCap to be better suited to more complex research designs.
If researchers would like to use a different survey tool, they must be mindful of the requirements to protect personally identifiable information (PII) of participants (or information, when combined with other information that could become personally identifiable). Not all surveys collect PII, but those that do must demonstrate to the REB that:
- Any PII is stored on Canadian servers. This is required to comply with the Personal Information International Disclosure Protection Act, and the Dalhousie Policy for the Protection of Personal Information from Access Outside Canada.
- If the PII is not to be stored on Canadian servers, then the risks to participants of having their data stored outside of Canada (and potentially subject to access by foreign governments), must be clearly presented in the consent documents.
11. I would like to invite Dalhousie medical students and/or residents to participate in my research study. Do I need any special permission for this?
Yes. Before making a submission to a Dalhousie University research ethics board, you must first secure the appropriate Faculty or department-level permissions. Documentation of this permission (or approval) must be appended to your Dalhousie University research ethics submission.
To conduct research involving medical students, please follow the guidelines and application form of the Undergraduate Medical Education Curriculum Committee.
To conduct research involving all residents, please follow the guidelines of the Postgraduate Medical Education Committee.
To conduct research involving residents of a particular program only, please secure the approval of the relevant Residency Program Committee.
12. I have REB approval to conduct in person interviews/focus groups, do I need to submit an amendment request to change or add remote interviews/focus groups?
Yes, this change will require an amendment request. In your amended submission, the sections that may require updating include:
- 2.4.1 Informed Consent - Describe any changes to the consent process, such as documenting verbal consent instead of a written signature.
- 2.5.1 Methods and Analysis - Describe how the interviews/focus groups will be conducted remotely. Include details such as which service/software will be used, what form of recording will occur (audio only or audio and visual), what type of recording device will be used (external or software integrated).
- 2.6.1 Privacy and Confidentiality – Explain how the recordings will be captured and stored (encryption of audio and video data is required) as well as the plans for retention and/or destruction of the recording. If videoconferencing will be used, address measures that will be taken to ensure privacy/confidentiality. Note that Microsoft Teams is Dalhousie’s approved videoconferencing tool. If you choose to use Zoom, refer to the guidance provided by Dalhousie ITS.
- Recruitment and Consent Materials - You may also need to update your recruitment materials if they reference in-person interviews and the consent form(s) (e.g. “what you’ll be expected to do”).